13 October 2004 
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Recently Approved Documents
Free Hormones (C45-A); Precision (EP5-A2); Arterial Collection (H11-A4); Patient Outcomes (HS6-A); Inpatient Medication Usage (HS10-A); Fluorescence Intensity (I/LA24-A); Cellular Immune Functional Assays (I/LA26-A)

NCCLS is pleased to announce that the following documents have been approved by the Board of Directors for publication.  See the text following this list for information on options for member and nonmember organizations to obtain copies.

C45-AMeasurement of Free Thyroid Hormones; Approved Guideline
This document addresses analytical and clinical validation of free (nonprotein-bound) thyroid hormone (FTH) measurement procedures.

HS6-AStudies to Evaluate Patient Outcomes; Approved Guideline
This guideline describes the essential issues in planning outcomes research, including resources needed, formulating a research question, validity and sources of error, feasibility, and ethical issues; addresses the design and implementation of a patient outcomes research plan, including study design, study subjects, measurements, interventions, and analysis; summarizes recommendations for reporting patient outcomes research; and includes definitions, references, and resources for those interested in planning, conducting, and using patient outcomes research.

-Second Notice-

EP5-A2Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition
This document provides guidance for designing an experiment to evaluate the precision performance of quantitative measurement methods; recommendations on comparing the resulting precision estimates with manufacturers’ precision performance claims and determining when such comparisons are valid; as well as manufacturers’ guidelines for establishing claims.

H11-A4Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition
This document provides principles for collecting, handling, and transporting arterial blood specimens to assist with reducing collection hazards and ensuring the integrity of the arterial specimen.

HS10-AApplication of a Quality System Model for Inpatient Medication Use; Approved Guideline
This document provides a model for providers of pharmacy services that will assist with implementation and maintenance of an effective quality system.

I/LA24-AFluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline
This guideline describes the basic principles, reference materials, and laboratory procedures upon which quantitative fluorescence calibration is based. 

I/LA26-APerformance of Single Cell Immune Response Assays; Approved Guideline
This document contains methods of intracellular cytokine evaluation, major histo-compatibility complex (MHC) tetramer quantitation, and enzyme-linked immunospot (ELISPOT) technology.  This document provides basic aspects of specimen collection, transport, and preparation, in addition to quality assurance and test validation approaches.


The NCCLS procedures have been designed to ensure that consensus has been achieved when a standard or guideline is published at the approved level. This means that a document has been rigorously reviewed by the authoring subcommittee, the area committee overseeing the project, the Board of Directors, and the medical-testing community which participates in the consensus process by carefully reviewing and commenting on the standard or guideline. The listed approved consensus documents are available for purchase.

You may automatically receive or select approved-level documents as a member benefit. For information on joining NCCLS, and viewing membership options and benefits, click here. [ return to top ]

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